Bioresorbable detachable tip design for adhesive-based extravascular closure device

ABSTRACT

A vascular closure device includes a vessel locating device, a sealant delivery device, a detachable sealing tip, and a suture. The vessel locating device includes an expandable portion configured to extend through and temporarily seal a vessel puncture from within a vessel. The sealant delivery device is configured to deliver a first volume of flowable sealant to the vessel puncture along an exterior of the vessel. The detachable sealing tip is carried at a distal end of the vessel locating device. The suture is connected to and extends proximally from the detachable sealing tip. The detachable sealing tip is configured for release within the first volume of flowable sealant upon withdrawal of the vessel locating device through the first volume of flowable sealant. The suture is anchored at a location proximal of the detachable sealing tip.

RELATED APPLICATION

This is a continuation of U.S. patent application Ser. No. 13/771,912filed on 20 Feb. 2013, now issued as U.S. Pat. No. 9,226,739, thedisclosure of which is incorporated, in its entirety, by this reference.

TECHNICAL FIELD

The present disclosure relates generally to methods and systems forsealing tissue punctures, and more particularly, to methods and systemsfor depositing and securing a secondary sealing member to seal tissuepunctures.

BACKGROUND

Various surgical procedures are routinely carried out intravascularly orintraluminally. For example, in the treatment of vascular disease, suchas arteriosclerosis, it is a common practice to access the artery andinsert an instrument (e.g., a balloon or other type of catheter) tocarry out a procedure within the artery. Such procedures usually involvethe percutaneous puncture of the artery so that an insertion sheath maybe placed in the artery and thereafter instruments (e.g., catheters) maypass through the sheath to an operative position within the artery.Intravascular and intraluminal procedures unavoidably present theproblem of stopping the bleeding at the percutaneous puncture after theprocedure has been completed and after the instruments (and anyinsertion sheaths used therewith) have been removed. Bleeding frompuncture sites, particularly in the case of femoral arterial punctures,is typically stopped by utilizing vascular closure devices.

While there are a variety of prior art devices and techniques forclosing such punctures, one method includes temporarily sealing thetissue puncture intravascularly using an inflation balloon. A sealingmaterial may be delivered to an outer surface of the tissue to seal thetissue puncture while maintaining the temporary seal from the balloon.Removing the collapsed balloon through the sealing material may leave achannel through the sealing material that poses a potential lack ofhemostasis. The channel through the sealing material may be closed bydepositing a detachable tip in the tract. Opportunities exist forimprovements in detachable tip constructions and methods of placement.

SUMMARY

One aspect of the present disclosure relates to a vascular closuredevice, which includes a vessel locating device, a sealant deliverydevice, a detachable sealing tip, and a suture. The vessel locatingdevice includes an expandable portion configured to extend through andtemporarily seal a vessel puncture from within a vessel. The sealantdelivery device is configured to deliver a first volume of flowablesealant to the vessel puncture at an exterior surface of the vessel. Thedetachable sealing tip is carried at a distal end of the vessel locatingdevice. The suture is connected to and extends proximally from thedetachable sealing tip. The detachable sealing tip is configured forrelease within the first volume of flowable sealant upon withdrawal ofthe vessel locating device through the first volume of flowable sealant.The suture is anchored proximal of the detachable sealing tip.

The suture may be connected to a distal end of the detachable sealingtip. The suture may be connected to a proximal end of the detachablesealing tip. The detachable sealing tip includes an elongate cylindricalshape. The detachable sealing tip may include a mesh material. Thesuture may wrap around the detachable sealing tip. The suture may beconnected to a securement member, which contacts an outer skin surfaceof the patient.

The suture and detachable sealing tip may each include a bioresorbablematerial, wherein the bioresorbable material of the detachable sealingtip has a faster rate of resorption than a material of the suture. Thedetachable sealing tip may include a lumen extending between distal andproximal ends of the detachable sealing tip, and the suture extendsthrough the lumen. At least a portion of the detachable sealing tip maybe positioned within the vessel locating device prior to being detachedwithin the first volume of flowable sealant. The sealant delivery devicemay include first and second lumens, the first volume of flowablesealant is delivered through the first lumen, and the vessel locatingdevice extends through the second lumen.

Another aspect of the present disclosure relates to a vascular closuredevice for sealing a vessel puncture of a patient. The vascular closuredevice includes a sealant delivery device and a detachable sealing tipassembly. The sealant delivery device is configured to deposit a volumeof flowable sealant adjacent to a vessel puncture. The detachablesealing tip assembly is configured to seal a channel formed in thevolume of flowable sealant upon removal of the vascular closure devicefrom the patient. The detachable sealing tip assembly includes a carriertube, a sealing tip positioned at a distal end of the carrier tube, asuture having a distal end releasably connected to the sealing tip and aproximal end extending outside of the patient, and a securement deviceconnected to the proximal end of the suture and configured to anchor thesealing tip against an outer skin surface of the patient after thesealing tip is released from the carrier tube within the channel.

The suture may fix the sealing tip relative to the carrier tube untilthe sealing tip is released in the channel. The securement device may beconnected to the suture after removal of the vascular closure devicefrom the patient. The vascular closure device may include an expandableballoon mounted to the carrier tube at a location proximal of thesealing tip. The expandable balloon may be operable to temporarily sealthe vessel puncture during delivery of the volume of flowable sealant.At least a portion of the sealing tip may be carried within a distal endportion of the carrier tube.

Another aspect of the present disclosure relates to a method of sealinga vessel puncture in a patient. The method includes providing a vascularclosure device having a sealant delivery device, a sealing tip, and asuture connected to the sealing tip. The method also includes advancingthe vascular closure device to the vessel puncture, and delivering avolume of flowable sealant to the vessel puncture with the sealantdelivery device. The method further includes withdrawing a portion ofthe vascular closure device through the volume of flowable sealant todefine a channel in the volume of flowable sealant, releasing thesealing tip in the channel, extending the suture proximally from thesealing tip, and connecting the suture to the patient.

The method may also include providing a suture securement device, andconnecting the suture securement device to the suture to anchor thesealing tip against an outer skin surface of the patient. The suture andsuture securement device may retain the sealing tip from moving distallythrough the vessel puncture. The method may include retaining thesealing tip to the vascular closure device with the suture prior toreleasing the sealing tip in the channel. Connecting the suturesecurement device to the suture may include inserting the suture throughthe suture securement device and advancing the suture securement devicealong the suture to the outer skin surface.

The vascular closure device may include a vessel locating memberpositioned proximal of the sealing tip, and the method includesinserting the vessel locating member through the vessel puncture andexpanding the vessel locating member to temporarily seal the vesselpuncture while delivering the volume of flowable sealant to the vesselpuncture. The method may include delivering another volume of flowablesealant to the channel after releasing the sealing tip in the channel.

The foregoing and other features, utilities, and advantages of theinvention will be apparent from the following detailed description ofthe invention with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate various embodiments of the presentdisclosure and are a part of the specification. The illustratedembodiments are merely examples of the present disclosure and do notlimit the scope of the invention.

FIG. 1 is a side view of an example vascular closure device inaccordance with the present disclosure.

FIG. 1A is a cross-sectional view of the vascular closure device of FIG.1 taken along cross-section indicators 1A-1A.

FIG. 1B is a cross-sectional view of the vascular closure device of FIG.1 taken along cross-section indicators 1B-1B.

FIG. 2 is an exploded view of the vascular closure device of FIG. 1.

FIGS. 3-12 shows example method steps of sealing a vessel puncture usingthe vascular closure device of FIG. 1.

FIGS. 13A and 13B show another example detachable sealing tip for usewith the vascular close device of FIG. 1.

FIG. 14 shows another example detachable sealing tip for use with thevascular close device of FIG. 1.

FIG. 15 shows another example detachable sealing tip for use with thevascular close device of FIG. 1.

FIG. 16 shows an example retention member for securing a suture of thevascular close device of FIG. 1.

Throughout the drawings, identical reference numbers designate similar,but not necessarily identical, elements.

DETAILED DESCRIPTION

The systems and methods disclosed herein may be used to close or sealpercutaneous punctures made through the body tissue of a patient to gainaccess to a body cavity of a patient. Access through these percutaneouspunctures allows a physician to carry out various procedures in orthrough the body cavity for examination, surgery, treatment and thelike. While not meant to be limiting, the systems are illustrated beingused to seal percutaneous punctures that provide access to blood vesselsin patients for various procedures. It will be appreciated that thesystems are applicable to other procedures requiring sealing of apuncture through body tissue into a cavity including, for example,laparoscopic surgery and other microscopic surgery techniques using arelatively small incision.

The general structure and function of tissue closure devices used forsealing a tissue puncture in an internal tissue wall accessible throughan incision in the skin are well known in the art. Applications ofclosure devices including those implementing principles described hereininclude closure of a percutaneous puncture or incision in tissueseparating two internal portions of a living body, such as punctures orincisions in blood vessels, ducts or lumens, gall bladders, livers,hearts, etc.

As used in this specification and the appended claims, the terms“engage” and “engageable” are used broadly to mean interlock, mesh, orcontact between two structures or devices. Likewise “disengage” or“disengageable” means to remove or capable of being removed frominterlock, mesh, or contact. A “tube” is an elongated device with apassageway. The passageway may be enclosed or open (e.g., a trough). A“lumen” refers to any open space or cavity in a bodily organ, especiallyin a blood vessel. The words “including” and “having,” as well as theirderivatives, as used in the specification, including the claims, havethe same meaning as the word “comprising.”

An example embodiment of the present disclosure includes a vascularclosure device having a detachable sealing tip. The vascular closuredevice is used with a sheath that provides access through a vesselpuncture and into an inner lumen of the vessel. The vascular closuredevice operates to release a detachable sealing plug (e.g., sealing tip)from a distal end of the vascular closure device after deployment of aflowable sealant at the vessel puncture. The vascular closure device mayinclude a sealant delivery device and a vessel locating device (alsoreferred to as a temporary sealing device) such as a balloon locationdevice. The locating device is inserted through the vessel puncture,expanded and anchored against an internal surface of the vessel adjacentto the vessel puncture. The sealant delivery device deposits a volume offlowable sealant along an external surface of the vessel adjacent to thevessel puncture. After the sealant is deposited and cured, the locationdevice is withdrawn through the sealant, which leaves an opening orchannel through the sealant. The channel may be sealed by locating andreleasing the sealing tip within the channel. The sealing tip may becarried at the distal end of the vascular closure device to improve easeof positioning the sealing tip within the channel.

The sealing tip may be secured at the distal end of the location deviceusing an elongated connection member such as, for example, a filament(e.g., a wire or suture) or other linkage that extends along a length ofthe vascular closure device from the sealing tip at a distal end of thelocation device to a proximal end of the vascular closure device. Thesealing tip is released from the distal end of the location device byreleasing the connection member at the proximal end of the vascularclosure device. In one example, the connection member is released byoperating an actuation member such as a lever or other feature. Theactuation member may be carried by a housing or handle at a proximal endportion of the vascular closure device. Releasing the connection memberat the proximal end allows the sealing tip to release from the distalend of the location device. The connection member is typically heldunder tension to retain the sealing tip at a distal end portion of thevascular closure device until the sealing tip is properly positionedwithin the deposited volume of sealing material.

The connection member may be released in a number of ways, such as, forexample, breaking the connection member using a tension force or cuttingthe connection member at any location along a length of the locationdevice. In another example, a knot or other connection feature used tosecure the connection member to the location device may be released todisconnect the connection member from an anchor feature such as, forexample, the housing. The actuation member mention above may be used torelease the connection member from the vascular closure device.

The examples disclosed herein may provide an improved design for abioresorbable sealing tip (e.g., a detachable sealing tip or detachableplug), which is one of the sealing components used for an adhesive-basedextravascular closure device. The new detachable tip design may combineat least some of the advantages and address at least some of thedisadvantages of existing designs, and is intended to enhance in vivodevice safety and minimize device profile while maintaining performance.The detachable tip may provide an immediate and secure vascularhemostasis regardless of, for example, anticoagulation status of thedeposited bioadhesive, the presence of peripheral vascular disease, andlow-stick location.

The example vascular close device as disclosed herein may implement adelivery system to position a flowable resorbable bioadhesive and aresorbable detachable tip at the site of a vessel puncture to provideimmediate and secure hemostasis. The vessel puncture is typically in therange of about 5 F to about 20 F. Vessel punctures in the range ofgreater than 10 F may be classified as “large bore” vessel punctures.The vascular closure device may include a balloon location device totemporarily seal the vessel puncture from within the vessel duringdelivery of a first treatment of bioadhesive (e.g., sealing material) tothe vessel puncture site. The bioadhesive may cure within a time frameof about 5 seconds to about 60 seconds, and more specifically, in therange of about 5 seconds to about 10 seconds. After the bioadhesive isat least partially cured, the balloon may be deflated and removed fromthe vessel. A channel is formed through the bioadhesive upon withdrawalof the balloon location device. The detachable tip may be deployed inthe channel as the balloon location device is removed through thebioadhesive. The detachable tip may provide temporary field control(i.e., flow through the channel) until, for example, a second treatmentof bioadhesive or other means of closing the channel and tissue tractleading to the vessel puncture is positioned. In the case of using asecond treatment of bioadhesive, the detachable tip may be locked inplace within the channel using the second treatment of bioadhesive. Thesecond treatment of bioadhesive may reinforce the initial or firstdelivery of bioadhesive.

Typically, the detachable tip provides a temporary seal with thebioadhesive channel, which may be helpful in limiting blood flow fromentering the tissue tract. The detachable tip may also limit passage ofa secondary injection of bioadhesive from entering the vessel throughthe vessel puncture. The detachable tip may comprise a bioresorbablematerial comprising, for example, any of the many known bioresorbableimplant materials. Preferably, the detachable tip is as small aspossible while still having a size sufficient to at least temporarilyplug the channel through the first injection of bioadhesive. Thedetachable tip preferably includes tip attachment and separationfeatures that provide a relatively safe, reliable and repeatable closureof the channel.

The detachable sealing tip of the present disclosure may comprise both adetachable tip and a connection member such as a filament (e.g., suture)attached to the sealing tip. The suture may be configured to extendthrough at least a portion of the tissue tract, and may specificallyextend to a location outside of the patient. An optional skin securementfeature may be used to connect and anchor the suture to the outside ofthe patient (e.g., against the outer skin surface of the patient). Thesuture extends proximally from the sealing tip and may be secured to thebioadhesive, which has been deposited within the tissue tract adjacentto the vessel puncture. The bioadhesive may provide anchoring of thesealing tip to limit distal movement of the sealing tip. When using theskin securement feature, the sealing tip may be additionally anchoredvia the suture and skin securement feature outside of the patient.

The detachable sealing tip of the present disclosure (e.g., includingthe suture and optional skin securement feature) may limit thepossibility of the detachable tip slipping into the vessel and causingpotential emboli risk to the patient during or after the secondbioadhesive injection, as well as during resorption of the bioadhesive.Resorption of the bioadhesive may occur within about 30 days to about 90days.

The detachable sealing tip and suture may comprise a bioresorbablematerial. The materials for the sealing tip may comprise, for example,crystalline/amorphous solid polymers or porous mesh structures (e.g.,polyglycolide acid (PGA), polylactic acid (PLA), or polylactic-co-glycolic acid (PLGA)). The suture may comprise, for example,commercially available PGA, PLA or PLGA. The resorption rate of thesuture material may be slower than the resorption rate of the detachablesealing tip and bioadhesive materials. The readily available materialsrecommended for the sealing tip and suture include, for example, a PLGAsealing tip and a PGA coated suture.

The sealing tip may be carried at a location at least partially spaceddistal of a distal most end of the balloon location device. In otherarrangements, at least a portion of the sealing tip is positioned withinthe balloon location device or otherwise within the vascular closuredevice during delivery. In the case of a sealing tip that comprises amesh material, the mesh may be compacted and inserted within a cavity ata distal end of the balloon device and later ejected from the cavity fordeposit within the channel formed in the bioadhesive.

A suture release mechanism may be integrated into the vascular closuredevice. The suture release mechanism may comprise, for example, a lowforce, controlled tip release, which is operable after the balloon isdeflated and removed from the vessel. The suture, which is tetheredproximally from the sealing tip, may be embedded within, for example,the second injection of bioadhesive upon curing to achieve immediatesecurement. As discussed above, the suture may optionally be connectedto a skin securement device, which is positioned at least partiallyoutside of the patient and may contact an outer skin surface adjacent tothe tissue tract leading to the vessel puncture. In at least someexamples, the skin securement device may be used in place of the secondejection of bioadhesive to anchor the sealing tip.

Referring now to FIGS. 1-2, an example vascular closure device 10 isshown including a manifold 12, a delivery tube 14, a balloon locationdevice 16, and a detachable sealing tip assembly 18. FIG. 2 shows thevascular closure device 10 at least partially exploded to separate themanifold 12 and delivery tube 14 from the balloon location device 16 andthe detachable sealing tip assembly 18. A suture of the detachablesealing tip assembly 18 extends through the balloon location device 16.A sealing tip of the detachable sealing tip assembly 18 is positioned ata distal end of the balloon location device 16 when assembled. Theballoon location device 16 is positioned extending through the manifold12 and delivery tube 14 and may be positioned at a distal most point onthe vascular closure device 10.

The manifold 12 includes a delivery device passage 20, an injection port22, and a latch 24. The delivery device passage 20 includes a proximalseat 26. A portion of the balloon location device 16 extends into andseats within the delivery device passage 20 against proximal seat 26.The injection port 22 is configured to receive a volume of bioadhesive,which may be carried by, for example, a syringe as shown in FIGS. 3-6.The latch 24 is configured to connect to a sheath, such as sheath 2shown in FIGS. 3-6. The latch 24 provides connection of the vascularclosure device 10 to the sheath to provide a fixed spacing between adistal most end of the sheath 2 and a balloon 34 of the balloon locationdevice 16.

The delivery tube 14 includes a first lumen 30, a second lumen 32, andthe balloon 34. The second lumen 32 terminates at a distal opening 36.The second lumen 32 is coupled in flow (e.g., fluid) communication withthe injection port 22 for delivery of bioadhesive to the vesselpuncture. The first lumen 30 receives the balloon location device 16 asshown in FIG. 1A. A space between the balloon location device 16 and asurface that defines the first lumen 30 provides a passage for deliveryof inflation fluid to the balloon 34. The balloon 34 may include distaland proximal waists 38, 40. In some arrangements, the proximal waist 40is connected to an outer surface of the delivery tube 14, and the distalwaist 38 is connected to a portion of the balloon location device 16. Insome embodiments, the balloon 34 is considered part of the balloonlocation device 16 rather than part of the delivery tube 14.

The balloon location device 16 comprises a housing 50, an inner tube 52,an inner tube manifold 54, an inflation manifold 56, a piston 58, and abiasing member 60. The piston 58 and biasing member 60 may be positionedwithin the housing 50 and provide a visual indicator of, for example, aninflated state of the balloon 34 as described in U.S. Patent ApplicationNo. 61/590,000, filed on 24 Jan. 2012 and entitled “Balloon LocationDevice Manifold for Vascular Closure Device and Methods,” which patentapplication is incorporated herein in its entirety by this reference.The inner tube 52 may include proximal and distal ends 62, 64 and definea lumen 66. The inner tube manifold 54 may be positioned at the proximalend 62 and provide attachment to, for example, a secondary source ofbioadhesive as shown in FIG. 10. In one example, the distal waist 38 ofthe balloon 34 is connected at the distal end 64 of the inner tube 52.

The inflation manifold 56 may be connected to a source of inflationfluid 7 as shown in FIGS. 3-6. The inflation manifold 56 may be coupledin flow of communication with the first lumen 30 of the delivery tube14.

The detachable sealing tip assembly 18 includes a filament 70 (alsoreferred to herein as a suture) and a sealing tip 72. The filament 70includes distal and proximal ends 80, 82. The filament may be connectedto the sealing tip 72 using, for example, a knot 84 (see FIG. 1B).

The sealing tip 72 includes distal and proximal ends 74, 76, and anattachment portion 78. The attachment portion 78 may be positioned atthe proximal end 76. The attachment portion 78 may be in the form of,for example, an eyelet, aperture, or protrusion that provides astructure for anchoring of the filament 70 to the sealing tip 72. Theattachment portion 78 may be formed integrally with the sealing tip 72,or may be formed separately and attached to the sealing tip 72 in aseparate attachment step.

The sealing tip 72 may be in the form of a capsule having a generallycircular cross-section with rounded surfaces at the distal and proximalends 74, 76. Other constructions are possible for the sealing tip 72,such as those shown in FIGS. 13A-15. FIGS. 13A and 13B show a sealingtip 172 formed of a mesh material. The mesh material may have anydesired shape and size. In one example, the mesh material has noparticular shape. The filament 70 may be wrapped around an outer surfaceof the sealing tip 172 and secured with a knot 184. In other examples,the filament 70 may be secured to the sealing tip 172 using, forexample, stitching, stapling or other attachment methods. The sealingtip 172 may be compacted and inserted within an inner tube 152 of aballoon location device. The inner tube 152 may include a lumen 166 anda sealing tip cavity 167. The filament 70 may extend through the lumen166 and connected to the sealing tip 172, which is positioned within thesealing tip cavity 167. In some examples, the sealing tip 172 may beejected out of the inner tube 152 using, for example, an ejection membersuch as a tube, which extends over the filament 70, through the lumen166 and into contact with a proximal end surface of the sealing tip 172.In other examples, the sealing tip 172 automatically moves out of thesealing tip cavity 167 upon releasing tension in the filament 70.

FIG. 14 shows another embodiment of a sealing tip 272 having distal andproximal ends 274, 276 and a tip bore 275. In some examples, the sealingtip 272 has a construction similar to the sealing tip 72 but with theaddition of tip bore 275. The filament 70 may extend through the tipbore 275 and be anchored at the distal end 274. A knot 284 may be formedin the filament 70 to provide the anchoring the distal end 274. In otherexamples, the filament 70 may be co-molded with the material of thedistal end 274. Anchoring the filament 70 at the distal end 274 mayresult in at least some rotation force being applied to the sealing tip272 if the sealing tip 272 attempts to move distally. This tendency ofthe sealing tip 272 to rotate upon moving distally may provide furtherresistance to distal motion.

FIG. 15 shows another example sealing tip 372 having distal and proximalends 374, 376, an attachment point 378, and at least one barb member379. The filament 70 is attached at the attachment point 378. The barb379 may extend radially outward from the tube that carries the sealingtip 372. The barb 379 may contact (e.g., embed within) the channel inwhich the sealing tip 372 is positioned. The barb 379 may help removethe sealing tip 372 from the tube that carries the sealing tip 372 uponreleasing tension in the filament 70.

FIG. 15 also shows a greater portion of the proximal end 376 positionedwithin the tube carrying the sealing tip 372 as compared to otherexamples shown herein. Extending a portion of the sealing tip 372 withinthe tube may help stabilize and maintain an axial orientation of thesealing tip 372 during delivery into the vessel and later positioningwithin the channel of the bioadhesive.

Other options are available for attaching the filament 70 to a sealingtip. In one example, a distal end portion of the filament 70 may beco-molded within the sealing tip. In another example, the filament 70may be weaved through a plurality of holes formed in the sealing tip. Asdiscussed above, the sealing tip may be formed into a solid structuresuch as the capsule-shaped structure of sealing tip 72. Alternatively,the sealing tip may comprise a deformable material such as, for example,the mesh material of sealing tip 172.

Referring now to FIGS. 3-11, an example method of sealing a vesselpuncture using a vascular closure device 10 is shown and described. FIG.3 shows a sheath 2 having a hub 4 and a distal end 6, which are advancedthrough a tissue tract 98 of a tissue layer 96, through a vesselpuncture 92 of a vessel 90, and into a vessel lumen 94. The vascularclosure device 10 is axially aligned with the hub 4. A first bioadhesivecarrier 8 may be mounted to the injection port 22 of the manifold 12. Aninflation fluid source 7 may be connected to the inflation manifold 56of the balloon location device 16. The filament 70 may be arranged withthe proximal end 82 extending proximally from the balloon locationdevice 16. A tension force T may be applied to the filament 70 tomaintain connection of the sealing tip 72 to the vascular closure device10. The tension force T may be maintained, for example, by securing thedistal end 80 of the filament 70 to a portion of the vascular closuredevice 10 such as, for example, the inner tube manifold 54, an actuatorassociated with one of the manifold 12 and housing 50, or a separatedevice that may be mounted to, for example, the inner tube manifold 54at a proximal portion of the vascular closure device 10.

FIG. 4 shows the vascular closure device 10 advanced through the sheath2 to position the balloon 34 and sealing tip 72 within the vessel lumen94. A volume of inflation fluid is advanced from inflation fluid source7 to the balloon 34 to inflate the balloon 34. The vascular closuredevice 10 and sheath 2 are withdrawn until the balloon 34 contacts aninner surface of the vessel 90 adjacent to the vessel puncture 92. Theinflated balloon 34 provides temporary hemostasis through the vesselpuncture 92.

FIG. 5 shows a volume of bioadhesive advanced into the tissue tract 98and vessel puncture 92. The volume of bioadhesive may be delivered byactuating the first bioadhesive carrier 8 (e.g., depressing a syringeplunger). The bioadhesive is ejected out of the distal opening 36 of thedelivery tube 14. The bioadhesive may form a first bioadhesive plug 5.The balloon 34 may limit movement of the first bioadhesive plug 5through the vessel puncture 92 into the vessel lumen 94.

After the first bioadhesive plug 5 is at least partially cured (e.g.,cured to the extent that the first bioadhesive plug 5 will not flow intothe vessel lumen 94 upon deflation of the balloon 34), the balloon 34 isdeflated and withdrawn through the first bioadhesive plug 5 as shown inFIG. 6. The vascular closure device 10 and sheath 2 are withdrawn adistance sufficient to position the detachable sealing tip 72 within aplug channel 3 in the first bioadhesive plug 5, which is formed uponwithdrawing the vascular closure device 10 as shown in FIG. 6. At thispoint, the operator may release the tension force T in the filament 70to release the sealing tip 72 from the balloon location device 16. Thefirst bioadhesive plug 5 may maintain the sealing tip 72 lodged withinthe plug channel 3 based at least in part on, for example, the size andshape of the sealing tip 72 along with properties of the sealing tip 72.The sealing tip 72 may provide hemostasis through the plug channel 3 atleast temporarily until further bioadhesive is delivered to the tissuetract 98 or the plug channel 3 collapses.

FIG. 7 shows the vascular closure device 10 and sheath 2 completelyremoved from the patient. The filament 70 extends through the tissuetract 98 to a location outside of the patient. The filament 70 may actas an anchor that helps hold the sealing tip 72 from moving distallyinto the vessel lumen 94. The filament 70 may be anchored by connectionto the first bioadhesive plug 5. An optional retaining member may beused to secure the filament 70 outside of the patient to provideadditional anchoring of the sealing tip 72.

FIG. 8 shows a retaining member 88 being advanced along the filament 70.The retaining member 88 may have an opening that provides one-waypassage of the filament 70 through the retaining member 88. Theretaining member 88 contacts the outer skin surface 97 of the patient asshown in FIG. 9 to help maintain tension in the filament 70, whichfurther anchors the sealing tip 72.

The retaining member 88 may be in the form of, for example, a disk. Thedisk may have a maximum width dimension (e.g., diameter) that is greaterthan the maximum width of the tissue tract 98 along the outer skinsurface 97. The retaining member 88 may help distribute the tensionforces in filament 70 across a greater surface area of the outer skinsurface 97.

FIG. 10 shows an alternative or additional step for anchoring thefilament 70 within the tissue tract 98. After depositing the sealing tip72 within the plug channel 3, the vascular closure device 10 may bewithdrawn to position the distal end 64 of the inner tube 52 proximal ofthe first bioadhesive plug 5 and within the tissue tract 98. A secondvolume of bioadhesive may be advanced through the inner tube 52. Thesecond volume of bioadhesive may be supplied by a second bioadhesivecarrier 8A. The second bioadhesive carrier 8A may be mounted to, forexample, the inner tube manifold 54.

The second volume of bioadhesive material may encapsulate at least aportion of the filament 70 within the tissue tract 98. Upon curing, thesecond volume of bioadhesive may form a second bioadhesive plug 9. Thesecond bioadhesive plug 9 may provide anchoring of filament 70 to helpretain the sealing tip 72 in a fixed axial position within plug channel3.

The second volume of bioadhesive may flow into the plug channel 3proximal of the sealing tip 72. The second volume of bioadhesive mayprovide hemostasis of plug channel 3 and may also directly contact andconnect to the sealing tip 72 within the plug channel 3.

FIG. 11 shows the vascular closure device 10 removed, with the first andsecond bioadhesive plugs 5, 9 sealing the vessel puncture 92 and tissuetract 98 and providing an anchoring function for the filament 70. Thefilament 70 may be additionally anchored using an external retainingmember such as retaining member 88 (see FIG. 12).

FIG. 16 shows an alternative retaining member 188. The retaining member188 is in the form of a bandage or tape through which the filament 70extends. The bandage may be secured to the filament 70 and may help holdthe filament 70 from moving distally. The retaining member 188 may besecured directly to the skin surface. In at least some arrangements, atleast a portion of the retaining member may extend through the skinsurface.

As discussed above, the materials used for the first and secondbioadhesive plugs 5, 9, the sealing tip 72, and filament 70 may beselected to maximize the anchoring effect of the filament 70. In oneexample, the materials of the filament 70 are resorbable at a slowerrate than the materials of the sealing tip 72 and the first and secondbioadhesive plugs 5, 9. In at least some examples, the sealing tip 72comprises materials that are resorbable at a faster rate than thematerials of the first and second bioadhesive plugs 5, 9.

Some example features and advantages related to the detachable sealingtip assemblies disclosed herein include, for example, providing atethered detachable tip for adhesive-based extravascular closure deviceshaving enhanced in vivo device safety and minimized device profile. Thetethered suture may secure the bioresorbable tip in the adhesive channelto limit the possibility of emboli risk to the patient if the detachabletip were to slip into the vessel. The detachable tip is not required tohave any specific geometry (e.g., outer diameter), which may provide theoption of having a lower device profile and improved manufacturingprocesses. The materials for the sealing tip and suture may includeexisting FDA-approved materials for similar clinical use, therebylimiting regulatory barriers. The biodegration profiles of thedetachable tip, suture and bioadhesive materials may be tunable in orderto achieve improved safety and other objectives during resorption. Thematerials for the sealing tip (e.g., solid or mesh) may be designed andintegrated with the vascular closure device for lower force, controlledtip release after the balloon is deflated and removed from the vessel.The tethered suture may be embedded within the second injection ofbioadhesive upon curing to provide immediate anchoring of the detachabletip. The detachable tip may be further secured using an additional skinsecurement component as described above.

While this invention has been described with reference to certainspecific embodiments and examples, it will be recognized by thoseskilled in the art that many variations are possible without departingfrom the scope and spirit of this invention. The invention, as definedby the claims, is intended to cover all changes and modifications of theinvention which do not depart from the spirit of the invention.

What is claimed is:
 1. A method of sealing a vessel puncture in apatient, the method comprising: providing a vascular closure devicehaving a sealant delivery device, a sealing tip, and a suture connectedto the sealing tip, the sealing tip having a proximal end surface;advancing the vascular closure device to the vessel puncture; deliveringa volume of flowable sealant to the vessel puncture with the sealantdelivery device; withdrawing a portion of the vascular closure devicethrough the volume of flowable sealant to define a channel in the volumeof flowable sealant; releasing the sealing tip in the channel; extendingthe suture proximally from the sealing tip with the suture being wrappedaround the proximal end surface of the sealing tip; connecting thesuture to the patient.
 2. The method of claim 1, further comprisingproviding a suture securement device, and connecting the suturesecurement device to the suture to anchor the sealing tip against anouter skin surface of the patient.
 3. The method of claim 2, whereinconnecting the suture securement device to the suture includes insertingthe suture through the suture securement device and advancing the suturesecurement device along the suture to the outer skin surface.
 4. Themethod of claim 2, wherein the suture and the suture securement deviceretain the sealing tip from moving distally through the vessel puncture.5. The method of claim 1, further comprising retaining the sealing tipto the vascular closure device with the suture prior to releasing thesealing tip in the channel.
 6. The method of claim 1, wherein thevascular closure device further includes a vessel locating memberpositioned proximal of the scaling tip, the method comprising insertingthe vessel locating member through the vessel puncture, and expandingthe vessel locating member to temporarily seal the vessel puncture whiledelivering the volume of flowable sealant to the vessel puncture.
 7. Themethod of claim 1, further comprising delivering another volume offlowable sealant to the channel after releasing the sealing tip in thechannel.
 8. A method of sealing a vessel puncture in a patient, themethod comprising: providing a vascular closure device having a sealantdelivery device and a scaling tip assembly, the sealant delivery devicehaving a distal end, the sealing tip assembly being partially within thedistal end and partially external to the distal end; positioning thevascular closure device within the vessel puncture; delivering a sealantmaterial to the vessel puncture with the sealant delivery device;withdrawing the sealant delivery device through a channel in the sealantmaterial; releasing the sealing tip assembly in the channel with aportion of the sealing tip assembly extending proximally from thesealant material; connecting the sealing tip assembly to the patient. 9.The method of claim 8, wherein the sealing tip assembly comprises asealing tip and a suture connected to the sealing tip, wherein theportion of the sealing tip assembly extending proximally from thesealant material comprises at least a portion of the suture.
 10. Themethod of claim 9, wherein connecting the sealing tip assembly to thepatient comprises connecting the suture to the patient.
 11. The methodof claim 8, wherein the sealing tip assembly is connected to the patientwhile the sealing tip assembly is partially positioned in the channel inthe sealant material.
 12. The method of claim 8, wherein the sealing tipassembly hemostatically seals the channel.
 13. The method of claim 8,wherein the sealing tip assembly is retained at the distal end of thesealant delivery device and releasing the sealing tip assembly comprisesseparating the sealing tip assembly from the distal end.
 14. The methodof claim 8, wherein the sealing tip assembly is retained to the sealantdelivery device by tension applied at a proximal end of the sealing tipassembly and wherein releasing the sealing tip assembly comprisesreleasing the tension applied at the proximal end.
 15. A method ofsealing a vessel puncture in a patient, the method comprising: providinga vascular closure device having a sealant delivery device and a sealingtip assembly, the sealant delivery device having an internal cavity at adistal end of the sealant delivery device, the scaling tip assemblybeing at least partially within the internal cavity; positioning thevascular closure device within the vessel puncture; delivering a sealantmaterial to the vessel puncture with the sealant delivery device;withdrawing the sealant delivery device through a channel in the sealantmaterial; ejecting the sealing tip assembly from the internal cavityinto the channel with a portion of the sealing tip assembly extendingproximally from the sealant material; connecting the sealing tipassembly to the patient.
 16. The method of claim 15, wherein the sealantdelivery device comprises a material compacted within the internalcavity and wherein the material expands upon ejection from the internalcavity.
 17. The method of claim 15, wherein the sealing tip assemblycomprises a suture tied around a scaling plug, and connecting thesealing tip assembly to the patient comprises connecting the suture tothe patient.
 18. The method of claim 15, wherein the sealing tipassembly automatically moves out of the internal cavity upon releasingtension applied to the sealing tip assembly.
 19. The method of claim 15,further comprising delivering a second sealant material to the vesselpuncture upon withdrawal of the sealant delivery device through thechannel.
 20. The method of claim 15, wherein the scaling tip assemblycomprises a suture extending through a bore in a sealing plug and thesuture extends proximally from the channel upon ejection of the sealingtip assembly from the internal cavity.
 21. A method of sealing a vesselpuncture in a patient, the method comprising: providing a vascularclosure device having a sealant delivery device, a sealing tip, and asuture connected to the sealing tip; providing a suture securementdevice; advancing the vascular closure device to the vessel puncture;delivering a volume of flowable sealant to the vessel puncture with thesealant delivery device; withdrawing a portion of the vascular closuredevice through the volume of flowable sealant to define a channel in thevolume of flowable sealant; releasing the sealing tip in the channel;extending the suture proximally from the sealing; connecting the sutureto the patient; connecting the suture securement device to the suture toanchor the sealing tip against an outer skin surface of the patient. 22.A method of sealing a vessel puncture in a patient, the methodcomprising: providing a vascular closure device having a sealantdelivery device and a sealing tip assembly, the sealant delivery devicehaving an internal cavity at a distal end of the sealant deliverydevice, the sealing tip assembly being at least partially within theinternal cavity, wherein the sealant delivery device comprises amaterial compacted within the internal cavity; positioning the vascularclosure device within the vessel puncture; delivering a sealant materialto the vessel puncture with the sealant delivery device; withdrawing thesealant delivery device through a channel in the sealant material;ejecting the scaling tip assembly from the internal cavity into thechannel, wherein the material expands upon ejection from the internalcavity; connecting the sealing tip assembly to the patient.